The present invention relates to the field of medicine, particularly to securing medical devices to tissue or organs, and to reversing the procedure and removing the devices.
The most common way to secure medical tissues to tissues or organs is by stapling with conventional surgical staples formed from a single length of wire in an approximate U-shape. For example, McGarry, et al., in U.S. Pat. No. 5,366,479, disclose endoscopic application of staples for attaching surgical mesh to body tissue in laparoscopic hernia surgery. In this patent, the stapler is a rigid instrument and cannot be used through the mouth into the esophagus where a flexible instrument is needed. Furthermore, the stapling system of this patent is not reversible.
For certain types of devices placed through the mouth, conventional stapling with a rigid stapler is not possible and so various alternatives using flexible instruments have been devised. For example, to treat a condition known as Gastro-Esophageal Reflux Disease (GERD), a tubular valve has been designed for letting free passage of food from the esophagus into the stomach but stopping food and gastric content such as hydrochloric acid and bile from refluxing from the stomach into the esophagus. Godin, U.S. Pat. No. 5,861,036, described a Gastro-esophageal Anti-Reflux Device (GARD) and Godin, U.S. Pat. No. 6,764,518 described a system for securing the GARD comprising a ring which could be collapsed into a smaller diameter for placement through the mouth and placed in a hiatus hernia after calibration of the diameter of the hernia with a catheter. Such ring was designed to place the GARD tubular valve in the lower esophagus or in a hiatus hernia associated with severe GERD and keep it in place for a significant amount of time, such as months and years, as severe GERD is a chronic condition.
While the aforementioned method of placing a GARD worked for some patients, it was insufficient in certain cases.
In a different approach to addressing GERD, endoluminal fundoplication surgery, a flexible endoscope was disclosed by Adams, et al., in U.S. Pat. No. 6,736,828, as being useful in endoluminal fundoplication surgery where a bonding agent is injected into tissue which forms an intussusception formed by pulling a selected portion of the esophagus into the stomach and displacing a fundus portion of the stomach towards the esophagus, placing a fastener across the intussusception for maintaining an esophageal wall and a gastric wall forming the intussusception adjacent to one another and then injecting the bonding agent to bond the intussusception. The disclosed fasteners are all symmetrical at both ends. Adams, et al., did not describe a flexible echo endoscopic procedure. The intussusception site is located by Adams, et al., by viewing the gastroesophogeal junction (GEJ) through the endoscope. The fastener is preferably made of polypropylene but can alternatively be made of a biocompatible material and can be a T-fastener. The fastener is inserted through a hypotube which first penetrates tissue of both the esophageal and gastric walls; then the T-fastener is inserted so the distal end of the T-fastener engages the gastric wall as the hypotube is retracted; and then the hypotube is further retracted into the sheath of a fastener delivery device. The proximal end of the T-fastener is pulled out of the hypotube by the tension exerted from the distal end of the T-fastener and then the proximal end seats against the inner wall of the esophagus, thereby holding the gastric wall and the esophagus together. One of the T-fasteners has a simple T-bar at each end, referred to herein as a fastener since the T-bars are normally biased in a T-configuration with respect to the longer joining portion but can be maintained in a reduced diameter configuration, with the T-bars “tilted” or compressed toward the longer joining portion, while inserted and maintained in a hypotube such as a hypodermic needle delivery device. Such fasteners are advanced through the hypotube until the distal portion exits the distal end of the hypotube delivery device and then regains its normally radially expanded position. In Adams, the T-bars when placed on both sides of the intussusception are visible on both sides with conventional endoscopes as one T-bar is on the esophageal side and the other one on the gastric fundal side. No echoendoscope is necessary and none is described. The Adams T-bars are not used to hold a device attached to the mucosa.
A system for suturing, tissue fixation, and transgastric penetration to facilitate surgery on the wall of the GI tract and adjacent hollow organs under Endoscopic Ultrasound (EUS) control was described by Fritscher-Ravens, et al., in Gastrointestinal Endoscopy, vol. 56, No. 5, 2002, pgs. 737 to 742. In this paper, one single tag is placed under EUS control through the mucosa. A free piece of thread as described in Figs. A-E on page 738 comes out of the tag and from the tip of the needle that is modified in order to let the thread come out of the needle. The free thread has then to be attached using either suturing systems or pledgets or tying knots that are not easily done or used through a flexible endoscope. Furthermore, the Fritscher-Ravens, et al., system was not described for use for securing medical devices, for example a GARD, to the gastrointestinal tract or any other organ.
A rigid rather than flexible laparoscopic surgery appliance for installing temporary plastic resorbable fasteners, for example for fixing parietal and visceral reinforcements, is described by Bailly, et al., in U.S. Pat. No. 6,779,701. Bailly, et al., teach binding nets for treatment of inguinal hernias. A plunger for forcing the catching bars to pivot is disclosed.
A self-securing suture wire with a T-shaped toggle designed for insertion into a bodily structure, tissue, or organ, delivered by a slotted needle, is disclosed by Levinson, et al., in U.S. Pat. No. 6,596,014. The toggle end portion can be made of nitinol, stainless steel, or biocompatible material. The suture is designed to be placed in a blood vessel from the outside of the vessel.
A T-bar fastener with a sharp end or point on the bar-like head portion, or T, so that the sharp end or point embeds itself in body tissue to securely anchor the T-bar head is disclosed by Richards, et al., in U.S. Pat. No. 4,669,473. A tool receives a fastener with the bar-like head positioned inside a bore of a sheath and the filament portion of the fastener extending out through a slot in the tool bore, the head making a sliding fit in the sheath.
Staples of various configurations have been suggested for unrelated surgical procedures and applications, for example for repair of arteries, Phillips, et al., US Patent Pub. 2003/0033006, disclose a device with a central section for abutment contact with the inner wall of a graft and two elongate members with distal ends for contacting the outer wall of the artery when the device is pierced through the graft and the artery. In FIGS. 7 and 8 of Phillips, et al., a device with a central loop is shown in unstressed configuration and in stressed configuration in a delivery tube.
A suture anchor was described by Gatturna, et al., U.S. Pat. No. 5,192,303 wherein a coupling member at one end and a barb on the other end are used to anchor a suture to bone.
Irnich, et al., U.S. Pat. No. 3,814,104, disclose a pacemaker electrode with an electrode tip having two crossing arms and a central loop.
It is an object of the present invention to provide a method and apparatus for esophageal and gastrointestinal stapling.
It is another object to provide an improved device for effectively securing medical devices to a patient's inner mucosa and reversibly remove the staple.
It is a further object to provide an improved apparatus for securing a GARD valve to a hiatus hernia or wall of a gastro-intestinal tract of a patient suffering from severe GERD associated with a hiatus hernia.
A still further object is to provide an improved staple for stomach stapling surgery to treat obesity and a method of reversing such stapling surgery for obesity.
It is also an object to place a manometric probe or several manometric probes in the colon to treat Irritable Bowel Syndrome (IBS).
A still further object is to use the clips to staples with a joining ring and make stomach folds in the cardia, i.e., the upper part of the stomach, to make pleats to treat mild to moderate GERD.
A still further object is to use the staples to create a small reservoir in the upper part of the stomach to create a restrictive pouch in the stomach to treat moderate obesity, creating a reversible endoscopic vertical banding gastroplasty.
It is a further object to use pairs of staples to create a horizontal line of stapling creating a small gastric cavity at the top of the stomach, at the cardia, mimicking endoscopically the gastric pouch obtained by the laparoscopic banding (LAP-BAND) operations for obesity.
It is a further object to provide an improved device for effectively securing restrictive and bypass tubes to treat obesity, called OB tubes as described in PCT/US06/35568.